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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4942

2. Registrant Information.

Registrant Reference Number: 2018EB133

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

12-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

08-JUN-18

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No. 29780      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

Units: mL

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

The patient is a 11.7 kg male neutered 8 year old boston terrier. On June 7th the pet owner applied 1 vial of K9 Advantix II large dog topically in one spot at the base of the neck of the patient.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Boston Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

11.7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
  • Ear
    • Symptom - Other
    • Specify - Ear canal erythema
    • Symptom - Other
    • Specify - Ear discharge
  • General
    • Symptom - Discomfort
  • Skin
    • Symptom - Hyperesthesia
  • General
    • Symptom - Other
    • Specify - Abnormal test result

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

The next day on June 8th, the patient had ear twitching every 10-20 seconds, seemed worse on the right ear. The ears were red with secretions. The patient was sensitive to the touch and uncomfortable. The patient was seen at the clinic on June 12th, a cytology was done that revealed bacteria and yeast in the right ear. The patient was treated with Surolan. The outcome is unknown.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

O - Unclassifiable/unassessable Would more expect twitching localized at application site than at ear after topical product application. Ear redness is not expected and may have numerous other potential causes. Being uncomfortable is unspecific and may have numerous other potential causes in a dog. Even though more expected after oral uptake, permethrin has the potential to cause slight neurological disorders in particular susceptible animals; however sensitive to touch is not expected. Ear secretion and further diagnosed bacteria and yeast in the ear are not expected after product application as inconsistent with pharmaco-toxicological profile of the product. Other causes should be considered. Though time to onset is consistent for initial reported signs, considering long time to onset for later reported signs (5 days), a product connection is unassessable.